ABBV-932 with itraconazole in bipolar disorder: how the drug moves through the body and what side effects occur

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study to assess safety and pharmacokinetics of ABBV-932 when given with oral itraconazole in adults with bipolar disorder. The study will monitor adverse events and measure how ABBV-932 is absorbed, distributed, metabolized, and excreted. Eligible participants are adults with bipolar I or II disorder who are generally healthy besides their condition. The trial is conducted at two U.S. sites, with AbbVie as the lead sponsor. Results could inform dosing and safety of future combination studies in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 38.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
* Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) primary diagnosis of bipolar I or II disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0.2).

Exclusion Criteria:

* Participants with bipolar I or II disorder subject psychiatric history:

  * Clinical Global Impression-Severity (CGI-S) \> 4 at Screening or Baseline.
  * History of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.
  * Major depressive or manic episode within the past 3 months prior to screening.
  * Lifetime history of schizophrenia spectrum or other psychotic disorders, dissociative disorders, or neurocognitive disorders.
  * History of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.
* History of suicidal ideation within 1 year prior to study treatment administration as evidenced by answering "yes" to any question on the suicidal ideation portion of Columbia Suicide Severity Rating Scale (C-SSRS) at screening and/or history of suicidal behavior within 2 years prior to study treatment administration as evidenced by any "yes" answer to suicidal behavior questions on the C-SSRS.
* History with any protocol prohibited medications, supplements, or herbal products, including any psychotropic drug or any drug with psychotropic activity (e.g., antipsychotic, antidepressant, anticonvulsant, mood stabilizer, herb, or over-the-counter medication with psychoactive potential) within 14 days or 5 half-lives of the medication (whichever is longer), prior to study treatment administration, with the exception of protocol-allowed medications listed in the protocol, including a total daily dose of ≤ 2 mg/day lorazepam.

Where it's running

• CenExel Collaborative Neuroscience Research /ID# 282784
  Los Alamitos, California, United States Recruiting
• Acpru /Id# 276951
  Grayslake, Illinois, United States Completed

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.